Friday, 13 February 2015

Sofosbuvir

It is well known that while a drug is protected by a patent, its price will be higher than it would otherwise be. This is, of course, the reason for having a patent. Sometimes this price can be very high indeed, for example where a patented drug is very much more effective than anything else currently available, for which people will be prepared to pay a lot more. In a free market, the price of any patented drug would be determined simply by how much the patent holder could get away with charging. The optimum price for the patent holder will be the one that maximises profits, which will of course not necessarily be the maximum price they can get away with. The market in drugs, however, doesn't always work like that, and in some cases the market is, for various reasons, not free at all. Whereas in the US, pharmaceutical companies can charge pretty much whatever they like and see what the market can bear, in Europe the situation is much more complicated. In the UK, the NHS will strike a deal with pharmaceutical companies to get the best price they can, and there is an incentive for the patent holder not to charge too much because otherwise the patented drug will not be considered cost effective by NICE and will therefore not be generally prescribed.

It is obvious that there are many factors in play when a patent holder decides what to charge for their drug in each country they wish to sell it in. In some countries it might not be possible to even get a patent for the drug. A decision will then need to be made on whether to market the drug in that country at all, if the price that can be charged is not worth it. In other countries where a patent is possible, a patent holder may need to charge the same price throughout an entire region, in order to prevent parallel importation from becoming a drain on profits. This is the case in Europe, where different deals may be struck in different EU countries, resulting in different prices being charged. Sometimes the price being demanded is so high that complaints start to be raised.

A recent complaint about high pricing relates to the price Gilead are currently charging for their patented drug Sofusbuvir (trade name: Sovaldi or Virunon), a new drug for treating hepatitis C virus (HCV) infections. In the UK, a price of £35,000 for a typical 12 week treatment course has been quoted (see the Wikipedia link above). NICE have as yet not issued any guidance as to whether Sofusbuvir should be funded on the NHS, although a decision is expected this month (see here).

In France, the issue has been raised by the charity Médecins du Monde, which describes itself as "an international humanitarian organisation providing medical care to vulnerable populations affected by war, natural disasters, disease, famine, poverty or exclusion". It has recently, however, apparently extended its remit to cover objecting when high prices are charged for patented drugs. A press release of theirs, issued on 10 February, states:

Today, Doctors of the World - Médecins du Monde (MDM) has filed a European patent challenge against the Hepatitis C virus (HCV) drug, sofosbuvir. In recent months, Médecins du Monde and its partners have raised the alarm around the problems caused by the cost of new treatments against hepatitis C and of sofosbuvir in particular. The U.S.-based pharmaceutical company Gilead holds a monopoly for sofosbuvir and is marketing a 12-week course treatment at extremely high prices – 41 000 euros in France and 44 000 euros in the United Kingdom – thereby hindering access to the drug for People Living with HCV.

A patent challenge is a legal procedure by which the validity of a patent is questioned. While using sofosbuvir to treat hepatitis C represents an important step forward, the molecule itself is not sufficiently innovative to warrant a patent. If successful, it can encourage competition from generic versions of sofosbuvir, which can drive price reductions closer to the cost of production. According to experts, this cost for sofosbuvir may be as low as $101 USD for a 12-week course.

Since Gilead is prioritizing its private rights over human rights, imposing unconscionable prices for healthcare systems, Doctors of the World – MDM has decided to challenge Gilead. This is the first time in Europe that a medical non-governmental organisation (NGO) uses this procedure to improve patient access to drugs. MDM believes that the price of sofosbuvir is unjust in part because public funds were used to research and develop the drug.

“We are defending universal access to healthcare: the struggle against health inequality involves safeguarding a healthcare system based on solidarity,” explains Dr Jean-François Corty, MdM’s French Programmes Director.“Even in a ‘rich’ country like France, with an annual medicines budget of 27 billion euros, it is difficult to meet this cost. We are seeing an arbitrary rationing approach that excludes patients from care, and this is unacceptable.”

According to the World Health Organisation (WHO), an estimated 130 to 150 million individuals are living with chronic hepatitis C. Within the European Union, it is estimated that between 7.3 and 8.8 million people are living with the virus. In France, 230, 000 people are reportedly chronic carriers of hepatitis C.

“Patent challenges have already been used by civil society in India, Brazil, the United States and around the world to remove weak or unmerited patents for drugs and to make low-cost generic versions available,” explains Olivier Maguet,MdM board member delegate for hepatitis C. “This has led to a substantial reduction in the cost of treatments, enabling access to drugs of patients who would otherwise be deprived of life-saving medicines.”
Doctors of the World - Médecins du Monde is taking up the fight to promote universal access to treatment against HCV in Europe and the rest of the world. MdM is also launching a public debate in France on the drug pricing mechanism and its impact on the healthcare system.

MdM do not actually indicate what patent is being opposed, but a copy of the opposition itself is linked to on this page, and states that the patent is EP2203462 (EP register here), which was granted on 21 May 2014. The deadline for filing oppositions does not end until 21 February 2015, so there is a chance that others may join in over the next few days, possibly making MdM's politically motivated contribution irrelevant. Given the very high value of the patent in question (which appears to be of the order of billions of whatever currency unit you favour), I think there is a very high probability of this happening. I suspect this one will run for a very long time, regardless of MdM's opposition.

UPDATE 20/2/15: As expected, more oppositions have been filed. Two further notices of opposition were filed yesterday: one by Dr. Holm Herbert Fleischer, a German doctor, and another by Ellis IP Limited (presumably acting as a straw man on behalf of an unidentified opponent). There seems to be a consistent theme among the three oppositions so far filed that there is an issue regarding the patent claiming the two stereoisomers of sofosbuvir, and in particular whether this is directly and unambiguously derivable from the application as filed (Article 123(2) EPC), whether the application discloses the invention sufficiently (Article 83 EPC) and whether the claimed invention has a valid right to priority (Article 87 EPC).

UPDATE 24/2/15: Four further oppositions have now been filed, making a grand total of seven now that the opposition deadline has passed. These extra four have been filed in the names of Actavis Group PTC ehf, STADA Arzneimittel AG, ZBM Patents and IPS. the latter two being apparently further strawmen oppositions. The six other oppositions, which were presumably made for sound commercial reasons rather than being politically motivated, make the MdM opposition seem a bit of a wasted effort.

UPDATE 5/3/15: The EP register now indicates a total of ten opponents, another three apparently getting in at the last minute. These are:

It looks like Gilead's representative (Sheila Wallace of Marks & Clerk) will be kept quite busy for some time.

In a related matter, a commenter has kindly pointed me to this article in the Grauniad. According to the author, who was lucky enough to have been successfully treated with sofusbuvir, socialism would be the answer to the problem of big pharma charging high prices for new drugs. He neglects, however, to explain how this would help in discovering these new drugs in the first place.

5 comments:

Sovaldi is "expensive", yes, but it might be a surprise to some readers (from the tone of the MdM comments above, at least) that it is far from the most expensive drug available. (I recall seeing a list recently showing it to be in the high-teens on a list of the most expensive drugs.)

The "$100" unit cost of the drug per se is not especially relevant, as it does not factor in the cost of research and development of the drug (nor the marketing budget which is typically even higher, although ironically that cost is publicized less). There is also the vastly reduced cost of care that the NHS can expect to spend on each patient that is cured of HCV; in terms of pure monetary cost-benefit-analysis, this overall reduced cost to the NHS must weigh heavily, despite the high headline cost of the drug.

There is no hiding from the high profits made by some pharmaceutical companies, but the picture is somewhat more nuanced than some of the more strident commentators would have it.

I have a suggestion. If a drug can be made for $100 per treatment, why don't MDM develop their own version and provide that? Surely they receive enough donations to pay the $100 R&D and manufacturing costs?

About Me

Tufty the Cat is the nom de chat of UK and European patent attorney David Pearce (LinkedIn profile). Anything written by Tufty should not be taken as constituting legal advice, and no responsibility is taken for anything you might do as a result.